I have been disturbed by the obvious mixture of po
Post# of 155523
(Total Views: 1026)
Posted On: 08/24/2020 9:10:13 AM
I have been disturbed by the obvious mixture of politics and science we saw on display yesterday.
However, let's go back to our investment.
We are good.
the FDA has not published their results. I don't know where did Steven Hahn get the 35 patients out of every 100 were saved. He either miss-spoke, is not good at math (a lethal trait for the commissioner of the FDA), or just said whatever pleased his boss after he was put under pressure:
Plasma has not been subjected to clinical trials. The only one in record in Holland was terminated:
https://www.medrxiv.org/content/10.1101/2020....20139857v1
So, the treatment does not work late into the COVID infection. According to the Dutch investigators plasma needs to be prioritized to risk groups with recent symptoms onset that may benefit from convalescent plasma.
We all want plasma to work for benefit of the patients. The studies published and carried so far show a small benefit that might or might not be real efficacy:
So, basically plasma was given to anybody, any time any level of antibody.
Let me be clear: at 7 days from every 100 patients there was a difference of 3.2 patients in mortality and 5.1 at 30 days. And they took the clue from the Dutch study and plasma results were was compared between interventions within 3 and 4 days.
We should be able to blow this numbers out of the water with Leronlimab when our CD-12 trials result come.
The bar has been set very low for us.
And, this against anecdotal evidence as these numbers are surely tainted as there is no placebo control and the intervention was not controlled. Everything you DO NOT WANT to have in a clinical double-blinded controlled trial.
And, please Mr. Hahn, give us the source of your conclusions.
However, let's go back to our investment.
We are good.
the FDA has not published their results. I don't know where did Steven Hahn get the 35 patients out of every 100 were saved. He either miss-spoke, is not good at math (a lethal trait for the commissioner of the FDA), or just said whatever pleased his boss after he was put under pressure:
Quote:
"The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics," Trump tweeted, continuing to push his unfounded theory that there is a "deep state" embedded within the government bureaucracy working against his reelection.
Plasma has not been subjected to clinical trials. The only one in record in Holland was terminated:
https://www.medrxiv.org/content/10.1101/2020....20139857v1
Quote:
Results The trial was halted prematurely after 86 patients were enrolled. Although symptomatic for only 10 days (IQR 6-15) at the time of inclusion, 53 of 66 patients tested had anti-SARS-CoV-2 antibodies at baseline. A SARS-CoV-2 plaque reduction neutralization test showed neutralizing antibodies in 44 of the 56 (79%) patients tested with median titers comparable to the 115 donors (1:160 vs 1:160, p=0.40). These observations caused concerns about the potential benefit of convalescent plasma in the study population and after discussion with the data safety monitoring board, the study was discontinued .
Quote:
No difference in mortality (p=0.95), hospital stay (p=0.68) or day-15 disease severity (p=0.58) was observed between plasma treated patients and patients on standard of care. Conclusion Most COVID-19 patients already have high neutralizing antibody titers at hospital admission.
So, the treatment does not work late into the COVID infection. According to the Dutch investigators plasma needs to be prioritized to risk groups with recent symptoms onset that may benefit from convalescent plasma.
We all want plasma to work for benefit of the patients. The studies published and carried so far show a small benefit that might or might not be real efficacy:
Quote:
Intervention: Transfusion of at least one unit of human COVID-19 convalescent plasma using standard transfusion guidelines at any time during hospitalization. Convalescent plasma was donated by recently-recovered COVID-19 survivors, and the antibody levels in the units collected were unknown at the time of transfusion. Main Outcomes and Measures: Seven and thirty-day mortality.
So, basically plasma was given to anybody, any time any level of antibody.
Quote:
The conclusion: The seven-day mortality rate was 8.7% in patients transfused within 3 days of COVID-19 diagnosis but 11.9% in patients transfused 4 or more days after diagnosis. The 30-day mortality rate was 21.6% vs. 26.7%.
Let me be clear: at 7 days from every 100 patients there was a difference of 3.2 patients in mortality and 5.1 at 30 days. And they took the clue from the Dutch study and plasma results were was compared between interventions within 3 and 4 days.
We should be able to blow this numbers out of the water with Leronlimab when our CD-12 trials result come.
The bar has been set very low for us.
And, this against anecdotal evidence as these numbers are surely tainted as there is no placebo control and the intervention was not controlled. Everything you DO NOT WANT to have in a clinical double-blinded controlled trial.
And, please Mr. Hahn, give us the source of your conclusions.
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